Technology-based Fall Risk Assessments for Older Adults in Low-income Settings

Sponsor
University of Central Florida (Other)
Overall Status
Completed
CT.gov ID
NCT06063187
Collaborator
National Institute on Aging (NIA) (NIH)
124
1
33
3.8

Study Details

Study Description

Brief Summary

The goal of this observational study is to examine the associations among fall risk appraisal, body composition, and physical activity in older adults in low-income settings.

The main questions it aims to answer are:
  • What is the feasibility of recruitment (e.g., how many older adults need to be screened to recruit the sample?), especially during the COVID-19 pandemic, and acceptability of technologies and procedures for use among older adults in low-income settings?

  • What are the the dynamic relationships between fall risk appraisal, body composition, physical activity, and behavioral changes related to fear of falling?

Participants will:
  • complete questionnaires about their characteristics, socio-demographic, medical history, cognition, depressive symptoms, anxiety, and fear of falling.

  • participate in static and dynamic balance tests, body composition measurement and handgrip strength test.

  • wear an accelerometer for physical activity assessment for 7 consecutive days.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The investigators will use a cross-sectional design to address aims. The investigators will administer the study instruments which consist of objective and subjective measures. Participants will complete questionnaires about their characteristics, socio-demographic, medical history, cognition, depressive symptoms, anxiety, and fear of falling.

    Balance performance will be assessed by the BTrackS Balance System (BBS). This test consists of four, 20 seconds trials. For each trial, the participants will stand as still as possible on the BBP with hands on their hips, and eye closed. This test consists of four trials. This test will take about 5-10 minutes.

    Body composition will be assessed using a bioelectrical impedance analysis (BIA): InBody S10. The BIA InBody S10 measures fat mass, muscle mass and body water levels. There are no risks, no dunking, no pinching, no discomfort associated with the use of bioelectrical impedance analysis. Test duration is 1-2 minutes.

    Physical Activity (PA) will be measured by activity monitoring devices. All participants will wear the ActiGraph GT9X Link wireless activity monitor (ActiGraph LLC.), a tri-axial accelerometer, on the non-dominant wrist for 7 consecutive days.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    124 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    Technology-based Fall Risk Assessments for Older Adults in Low-income Settings
    Actual Study Start Date :
    Sep 30, 2020
    Actual Primary Completion Date :
    Jun 30, 2022
    Actual Study Completion Date :
    Jul 1, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Feasibility of recruitment of low-income older adults [Through study completion, an average of 2 years]

      The investigators will assess the ability to recruit the participants by tracking the number of days and time spent to recruit the sample.

    2. Acceptability of using technologies in low-income older adults [Through study completion, an average of 2 years]

      The acceptability of the technologies and procedures will be examined based on an evaluation form (e.g., what the participants thought about the questionnaires and technology) and participants' recommendations.

    3. Maladaptive fall risk appraisal [Once at baseline, an average of 5 minutes]

      A condition in which there is a discrepancy between perceived fall risk (levels of fear of falling) and physiological fall risk (balance performance). Fear of falling will be assessed using the Short Fall Efficacy Scale International (short FES-I) with 7 items and balance performance will be assessed using the BTrackS Balance test. Maladaptive fall risk will be plotted on a electronic graph as the interaction between balance performance on the X-axis and fear of falling on the Y-axis.

    4. Time spent in each physical activity intensity domain [7 days]

      Participants will wear the ActiGraph GT9X Link wireless activity monitor (ActiGraph LLC.), a tri-axial accelerometer, on the non-dominant wrist for 7 consecutive days.This device will assess the time (minutes) spent in light, moderate, and vigorous physical activity domains throughout the 7-day assessment period.

    5. Body Composition [Once at baseline, an average of 2 minutes]

      Body composition will be assessed using a direct segmental multi-frequency bioelectrical impedance analysis (BIA): InBody s10 device.

    6. Balance Performance [Once at baseline, an average of 4 minutes]

      Balance performance will be assessed using the BTrackS Balance test.

    7. Fear of Falling [Once at baseline, an average of 10 minutes]

      Fear of falling will be assessed using the Short Fall Efficacy Scale International (short FES-I) with 7 items.The minimum score possible is 7 and the maximum possible score is 28. Scores of 7-8 indicate "low concern," scores of 9-13 indicate "moderate concern," and scores of 14-28 indicate "high concern."

    Secondary Outcome Measures

    1. Depression [Once at baseline, an average of 10 minutes]

      Depression will be assessed using the Patient Health Questionnaire-9 (PHQ-9). The minimum possible score is 0 and the maximum possible score is 27. Scores of 0-4 indicate "minimal depression," scores of 5-9 indicate "mild depression," scores of 10-14 indicate "moderate depression," scores of 15-19 indicate "moderately severe depression," and scores of 20-27 indicate "severe depression."

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    60 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • ≥ 60 years of age

    • no marked cognitive impairment [Memory Impairment Screen (MIS) score ≥5]

    • speak English or Spanish

    • live in Kinneret Sr. Apartments or in Orlando FL.

    Exclusion Criteria:
    • a medical condition precluding balance test (e.g., unable to stand on the balance plate) and/or PA (e.g., shortness of breath; feeling pressure when performing PA)

    • currently receiving treatment from a rehabilitation facility

    • have a metal implant.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Central Florida Orlando Florida United States 32816

    Sponsors and Collaborators

    • University of Central Florida
    • National Institute on Aging (NIA)

    Investigators

    • Principal Investigator: Ladda Thiamwong, PhD, RN, University of Central Florida

    Study Documents (Full-Text)

    More Information

    Publications

    Responsible Party:
    Ladda Thiamwong, Associate Professor, University of Central Florida
    ClinicalTrials.gov Identifier:
    NCT06063187
    Other Study ID Numbers:
    • STUDY00002473
    • R03AG069799
    First Posted:
    Oct 2, 2023
    Last Update Posted:
    Oct 2, 2023
    Last Verified:
    Sep 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Ladda Thiamwong, Associate Professor, University of Central Florida

    Study Results

    No Results Posted as of Oct 2, 2023